This point has been mentioned before, but not very prominently, in the discussions leading up to today's US Supreme Court review of the Wyeth v. Levine preemption case. AsThe Legal Times notes, a Democrat in the White House and a Democratic Congress could erase any preemption protection companies have won in the last eight years. Bills are already before Congress to do just that.
"If the Supreme Court gives Wyeth a big win, the trial lawyers have a big war chest and they can go to Congress and get rid of this preemption language," Victor Schwartz, a Shook Hardy & Bacon partner and longtime tort reform strategist, tells the paper. "If Obama comes in, it will be history."
You can tell such a movement is coalescing. Last week, the American Association for Justice, the trial lawyers' group, issued a report called 'Get Out Of Jail Free: How the Bush Administration Helps Corporations Escape Accountability,' and referred to a 'stealth campaign to preempt states' rights.'
Also last week, the House Committee on Oversight and Government reform released a report indicating key FDA career officials strongly objected to Bush Administration drug labeling regulations that would preempt state liability lawsuits. The staffers viewed justifications for the regs as 'false and misleading’ and warned changes would deprive consumers of timely info about drug safety, the report concluded.
39 Comments
Taske a look at comment 68 in the Levine thread, below -- it purports to be from a juror in the original case. LINK:
http://www.pharmalot.com/2008/10/preemption-the-business-case-of-the-century/#comment-380237
If it is genuine -- it is highly illuminating!
Namaste
Pre-emption is the most absurd policy protection the Bush administration has promoted... right up there with the rest of its ignorant doctrine of pre-emptive war. Drug companies should have to take their medicine, like everyone else.
What in the world does preemption mean? I know I am lame, but how can you blog on something without a background.
I wouldn't count on Obama to stand up for the little guy's right to sue. I remembered that he said he voted for tort reform a while back but I wasn't sure how he stood now so I went and did a google search to find out.
In the last debate McCain told Obama: “You’ll have to tell me one time you’ve stood up to the leaders of your party on one major issue.”
Obama reponse was: “First of all, in terms of standing up to the leaders of my party, the first major bill that I voted on in the Senate was in support of tort reform, which wasn’t very popular with trial lawyers, a major constituency in the Democratic party… So I’ve got a history of reaching across the aisle.”
Evelyn Pringle
It would be great to have a government that protects the rights of individuals, not just corporations.
Stop Preemption? I guess that means we won't go around the world any more, starting wars with other countries, using lies as a basis for attack. I guess it also means, that people who are damaged, or killed, due to the greed or irresponsibility of companies or others, will have the opportunity to get some justice. WHAT A CONCEPT!
Preemption will be history along with a number of other things uniquely American - Medical R&D Corporate residence Quality/efficient health care delivery Livable tax rate
And for Ronaldodo- Apparently it was OK for Iraq to attack Kuwait. If only we had sent Saddam a Hallmark card asking him to stop slaughtering his people, everything would have worked out perfectly and Saddam and his sons would be running a flower shop in Paris because they would left peaceably, Right?
As to your second naive insight - I guess the 20 gazillion lawyers in the phone book chasing ambulances for the last 50 years were doing it as a hobby since no one was ever successful suing a company.
Spare us your mind numbing banal drivel and your tacit implication that all things democrat good; all things republican bad. Your partisan mindset is exactly why nothing positive has happened since congress was gridlocked for the past dozen years.
I happen to be a constituent of Senator Obama's and so I wrote him a letter asking about his stance and his help on preemption. First I was glad to get a letter back; I think I might have posted it a number of months ago. I'll repost another copy later today.
Secondly I was very disappointed in his answer. He totally avoided the issue in his reply. I had to assume he comes down on the side of the corporate lawyers and torte reform. Then when I did hear his reply to questioning in the debate his stance became apparent.
Furthermore Obama is more than willing to accept the monetary support of most anyone with money including those with less than reputable character.
Lastly we see the monetary support of the pharma industry has turned conveniently from Republican to Democrat lately. Is it any wonder and will the Senator be able to resist the temptation? I imagine he's already been bought and paid for.
I would assume he will squash any attempt to overturn preemption in the Congress if it comes to that.
So if Obama is elected and if preemption is supported by the Supreme Court, I feel preemption is here to stay.
No the democrats (in congress) will not protect the little guy! They will protect themselves by making a bunch of lawyers rich so they will get big political donations. Remember the the big tobacco trials a few years ago, only the lawers and the states got rich. Then the states spent the monies on things other than what they promised. Here is something to think about. What is going to happen if it becomes to expensive to continue to stay in business. You may end up with only the government to develop new drugs. In that cast the would be no sueing the drug companies and we would not have the quality or quantity. Or it may come to the poing that we have only foreign developed durgs and about everything else. It would be a lot easer for a foreign company to pull oout of the US market than a domestic company.
Unfortunately, I am inclined to agree with Jaynesday and Evelyn. Based on "reliable sources" (so they seem), as well as what has been made public, any push to undo preemption is far more likely to come from Congress than the Exec. Obama might or might not go along, but it would take a very well crafted effort, particularly in the drug arena. (Devices much easier, as DDL often notes.)
As DDL also notes - although not with full consistency - the effort to undo implied preemption (which is the drug arena) will, at the least, be far more complicated than express preemption (which applies to devices). Will either branch have the will to do this?
My own guess is that it will, yet again, take a Vioxx scale disaster - or worse - to see significant action in that direction. And just to show again that I am a 'shill for trial lawyers,' I believe the trial lawyers - despite their own obvious interests - have also mostly let us down in the way they've responded to preemption. Like the mainstream media and most pols, they also mainly dropped the ball as far as fighting for citizens' rights.
So there, AAJ.
Freudian? - well, of course, there should have been a 'not' before the shill. But the truth is that, if being a shill could have helped fight preemption, I would have considered it.
Unfortunately, nobody asked me, and I didn't ask them. And I am genuinely furious at the indifference and relative incompetence in the way AAJ has responded to preempiton. Much too little, too late, too misinfored.
A comment on preemption. Preemption all the federal government to set the standard for all ot the US and its territories. If states are all to preempt the federal government what if each of the states decides they want something more than the feds have set. Then you would have 50 or more different standards to meet and manufacturing anything would be come to expensive make. Therefore it would be come much more costly to buy if you could find lit.
To "iamlame": No you're not. That's the thing--most people don't know what preemption is or why it's even an important issue right now.
The way preemption is described will change depending on who you ask, but it's basically an argument that one (federal) law overrides another (state-based) law or legal right. Preemption can be used to remove state based consumer lawsuits.
You can google Professors David Vladeck or Tom McGarrity to read more in-depth treatment of the issue. I also offer a short summary of preemption here.
Curly - your argument may apply to manufacturing goods, but that has nothing to do with FDA preemption. Preemption mostly covers "failure to warn" issues. So its absence has never required anyone to differently make anything. On the other hand, its absence - and the litigation to which it has led - has sometimes uncovered info that has led _the FDA_ to change warnings or, in some instances, to withdraw a drug - not because of a lawsuit, but because of suppressed data a lawsuit uncovered.
So I follow your logic, but it does not apply to FDA preemption. Essentially, the only time 'things' are changed is when manufacturing defects are uncovered. And then they are changed across the board.
I agree w/ Justice in MI, Evelyn, and Jaynesday. But if the trial bar has failed us, what can/must we do to bring substance to the debate?
Right now while this issue is hot and we've got a Supreme Court case, reports on government shadiness, and other issues coming to light, we've got to flood mainstream media with our opinion on this issue. The general public needs to see what's really at stake, and our reps need to be called out for blindly appealing to tort "reform" rhetoric without actually talking about how real people will be affected by policies like this.
Evelyn – I very much enjoy reading your articles.
Regarding Sen. Obama, what are the choices? We can only hope he will toss preemption into the garbage. There are no guarantees. However, it is highly unlikely John McCain would.
I was also concerned with Obama’s remark on tort reform, but tort reform and “preemption” are not one in the same.
As we know, the next president will be responsible for the selection of two or three Supreme Court Justices and their decisions will affect Americans for a very long time.
In the Pastor Rick Warren interview, John McCain made clear he favors Justices who support big business over American citizens, while Sen. Obama made clear he doesn’t. “Neither candidate shied away from a question about which current Supreme Court justice they would not have nominated. Obama's reply: Clarence Thomas.
‘I don't think he was a strong enough jurist or a legal thinker at the time for that. I profoundly disagree with his interpretation of the Constitution,’ he said.
McCain said he would have never nominated Justices Ruth Bader Ginsburg, Stephen Breyer, David Souter and John Paul Stevens.
‘This nomination should be based on the criteria on a proven record of strictly adhering to the Constitution and not legislating from the bench,’ McCain added.
The Arizona senator said he was ‘proud’ of President Bush for nominating conservative Justices Samuel Alito and John Roberts to the court.” http://www.cnn.com/2008/POLITICS/08/16/warren.forum/
The next president will also appoint the Solicitor General, considered to be the 10th Supreme court Justice.
I’m hoping for the best. That is all I can do.
I would have to agree with the many others on here, that although it would be nice, it just may be too difficult for Obama to get rid of preemption.
The time for deciding that is long past, he already took the money as contributions to his political campaign.
He will do what he is "supposed" to do....
The question is do the Supremes really represent "we the people", or have they been bought off and corrupted too?
Will trust and faith in our American government ever be restored? Perhaps we are a long way off from knowing the answer...
Here's to tomorrow!
Here is the letter from Senator Obama. I asked him specifically about his position on preemption and here's what I received.
Dear David:
Thank you for contacting me about the Supreme Court's ruling on preemption for medical device makers. Thank you for sharing your personal story with me. I appreciate your taking the time to inform me of your concerns.
I am gratified by the opportunity that the people of Illinois have given me to work on some very challenging issues that will affect our country’s future. This year, the U.S. Senate has considered – or will soon consider – important legislation relating to the President’s warrantless surveillance program, consumer protection, energy policy, and next year’s federal budget.
As I have approached these and other issues, I have appreciated the input I have received from Illinoisans like you. While lawmakers and their constituents may hold different perspectives at times, I feel it is particularly important that I hear the views of any Illinois resident who feels strongly about a particular issue. I can assure you that your opinion will be carefully considered if this issue comes before the Senate.
Finally, I want to apologize for the delay in my response. A real surprise and great pleasure of my first three years in the Senate has been the volume of letters and e-mails I receive daily from my Illinois constituents, which average up to 10,000 pieces a week. I hope that the delay in my response will not deter you from contacting me in the future about other issues of concern to you.
Sincerely,
Barack Obama United States Senator
Kia - Good to "see" you! My question - some of us have been trying to get to mainstream media for a very long time. We've had letters and occasional op eds, and stories when there are days like today, but that is about it.
Sometimes, I think ACT-UP had it right. Unless you know how to get a few hundred thousand people on the mall with relative ease.
I have believed that Obama would be on Pharma's side ever since he said he was glad Kennedy was supporting him and thus he could tap into his funding sources (i.e. Big Pharma).
At least on preemption I think it's possible that Grassley may have gotten McCain's ear.
This being said I think preemption is a crap shoot with either one and believe the best bet is with Congress.
Ir was either Stupak or Dingell (D-MI)who recommended a specific Republican as the next FDA Commissioner. This to me is a very strong endorsement. It would give Obama a chance to show that he's more inclusive and wants to heal the divisiveness that Bush has promoted, and it would also be a signal that he really means to change the FDA (as much as may be possible).
I've been uncomfortable since I saw how Waxman handled the Food Drug and Administration Act of 2007, but now that he's released the subpenoed e-mails from FDA staff I have to wonder if there might not be some hope after all.
Salmon
I think that Obama co sponsored the Senate's bill to overturn medical device preemption. That might be an indication of his leanings on this issue.
Forcing synthetic chemicals(med's) on humans was invented in Nazi Germany, and I read that med's kill 16,400% more Americans than foreign terrorists.
Good point Laura - It probably safe to say that the best way to know what a politician will do is to see what he/she does. Certainly don't try to figure it out by listening to what they say. I had forgotten about his support of the Senate bill. Happy Voting!
Kevin,
Your number is low. 16,400% is 16.4 times. Vioxx alone killed 60,000 which is 20 times higher than the number killed in the world trade center attack on 9/11.
Salmon
I just voted for the man, with great hope. The thought that he has been bought by Pharma has worried me - I know they gave alot to his campaign. But to think that he would support pre-emption and a totally (and on purpose) ineffective FDA are too much for me to take this Election Day. I count the responsibility for the death of my son from Zyprexa from the top down - starting with Worst President Ever Bush and landing in the lap of a vapid psychiatrist, listening to a lying Lilly drug rep.
The number I have in mind for those killed in the U.S. each year from prescription drugs is 100,000 - twice the number killed in the Vietnam War.
I WILL NOT BELIEVE ANY OF IT UNTIL I SEE IT HAPPEN AND PLAY THROUGH TO THE END IN TRUE JUSTICE. BECAUSE I NO LONGER BELIEVE THAT PRESIDENTS HAVE THIS KIND OF POWER. THE PEOPLE WHO OWN THE GLOBAL BANKS RUN THIS WORLD AND FAR OUTWAY ANY INFLUENCE AT ALL OVER ANY ONE AND ANY THING!! IN OTHER WORDS, THEY "OWN" THE PRESIDENCY, THE FDA, THE USA, INC. AND EVERYTHING ELSE IN THE WORLD UNLESS AND UNTIL WE ALL WAKE UP ENOUGH TO SEE IT WITH OUR OWN EYES AND REALIZE IT WITH OUR OWN TRUTH. THEY HAVE DUMBED US DOWN WITH FLUORIDE, MERCURY, THOUSANDS OF OTHER DRUGS AND CHEMICALS, LOW FREQUENCY WAVES, H.A.A.R.P., AND ON AND ON AND ON AND ON, AND MORE AND MORE CHEMTRAILS FILLING OUR SKIES, AND ON AND ON AND ON. THEY SAY THE PLANET IS OVERPOPULATED AND WANT THE POPULATION TO DROP FROM ALMOST 7+BILLION DOWN TO 550MILLION, AND "THEY" WILL SEE TO IT THAT IT IS DONE!!! "THEY" (word has it) HAVE WEAPONIZED THE 'AVIAN FLU' ACCORDING TO RIMA LAIBOW, MD. "THEY" HAVE REPLACED 80%+ OF OUR NATURAL FOOD TO GENETICALLY MODIFIED FRANKENFOODS, THEY WILL DISALLOW VITAMINS VIA "CODEX ALIMENTARIUS", AND CONTINUE TO INCREASE WATER FLUORIDATION, VACCINES WITH CANCER CAUSING VIRUSES AND MERCURY, ALL THE WAY TO CAUSING A GLOBAL FINANCIAL GLOBAL CRISIS AND CREATING MONEY, FOOD AND WATER WARS UNTIL THEY ACHIEVE THEIR GOALS....AND SOMEONE THINKS O-B-A-M-A WILL "FIX" THIS?????? HAVE WE ALL GONE MAD???? O.B.A.M.A......AS IN "Oh.Boy.America.Means.Anarchy."!!!!!!! ARE WE ALL REALLY THAT CRAZY???? WAKE UP PEOPLE, REMEMBER THE WIZARD OF OZ??? "PAY NO ATTENTION TO THAT MAN BEHIND THE CURTAIN", BECAUSE HE IS THE ONE THAT MAKES THE PUPPET CALLED OBAMA OR ANY ONE ELSE IN "OFFICE" MOVE TO THE WAY THEY PULL THE STRINGS. THIS IS NOT ABOUT OBAMA, THIS IS ABOUT THE GROUP THAT CALL THEMSELVES THE "GLOBAL ELITE", AND THEY PRINT THE MONEY AND THEY ARE TAKING AMERICA DOWN BY DESIGN. IT MAY ALREADY BE TOO LATE FOR 80%+ OF US, BUT....IF IT IS, AT LEAST DIE WITH YOUR EYES OPEN AND KNOW WHO IT IS THAT REALLY PULLED THE TRIGGER. DON'T BELIEVE ME!! LOOK IT UP YOURSELVES!! GO AHEAD AND GOOGLE THE NORTH AMERICAN UNION, GOOGLE THE "AMERO", GOOGLE AGENDA 21, GOOGLE "RED AND BLUE FEMA CAMPS" GOOGLE H.A.A.R.P., GOOGLE "PROJECT PAPERCLIP", READ JIM MARRS' BOOK "THE RISE OF THE FOURTH REICH", LOOK AT THE PLASTIC COFFINS VIDEOS ON YOUTUBE, LOOK AT THE 6000+ DETENTION CENTERS BEING BUILT BY HALLIBURTON AND CO. LOOK AT YOUTUBE VIDEOS OF THE "LEGO PRISON'S FOR THE BIG BOY'S" BY TINDALL CONSTRUCTION!!!! ASK YOURSELF WHY THE HELL ARE THEY BUILDING THEM! HAVE I GONE MAD??? YOU'RE DAMNED RIGHT I'VE GONE MAD!!! AND SO AS IT WAS PORTRAYED IN THE MOVIE "THE NETWORK", "I'M A HUMAN-BEING, G.D.IT, MY LIFE HAS MEANING!!! YOU'VE GOT TO GET MAD!! YOU'VE GOT TO GET GOOD AND MAD!!! (sorry, I needed an outlet and this was wide open. Let's see if there really still is a 1st right ammendment to free speech. Will this get posted??????)
Laney, I was posted but I only read the first 3 sentences. Sorry.
This is dirty business no matter what is decided in an election or a Supreme Court ruling. We lost a grown child to an anti-depressant. Given by an internist. One appointment. We did not know any of this dirty, greedy business existed. We were living our good, decent life. Our child is gone. Of course, the big drug companies want pre-emption.
GO OBAMA ...
Maybe now with America's new president elect , there will be some hope for change in the pharmaceutical industry..
Imagine an industry based on humanity, compassion and patient welfare and not profit, corruption and greed...
Maybe a little too much to ask for.. Suppose we can dream though eh?
:)
PREENPTION... this should never happen. If our children or grandchildren are hurt or die as a result of negelence from the phar company' drugs we should be able to make them responsible. Premption i feel will make them more lapsed in there research because they are protected by this. What happened to justice for all.
ops PREEMPTION
Lets face it folks we, the U.S., is a pill-popping nation and we want to take more and more pills to make our ailments go away. (And its easy to do) Drug companys are in the business to help people, but they are also in the business to make money. Medicine has come a long way, and is certainly much more advanced than it was. People are living longer. It would be illogical to expect someone to turn away from medical treatment because a few cases of something going wrong. Would you expect people to stop going to doctors and deny themselves treatment because of this and that we "must" prove all of medicine wrong first before taking them. How many people are better off today with modern medicine? Alot. That being said, the FDA does and has an obligation to do its "due diligence" when giving the "okay" to highly sensitive drugs coming to market. Obama and co need to do their due diligence with the next FDA. There are risks to everything in life and we all need to stop looking for a scapegoat when something goes wrong.
Yes we have become a pill-popping nation but never underestimate the power of persuation when considering how we got to the point where we so willingly believe that we have all these bogus diseases.
We've got non-stop commercials and half the doctors in this country are now little more than legal drug-pushers.
I used to be a member of the pill-popping population but after investigating Big Pharma steady since mid-2004, I'd have to be dying before I'd take a drug that wasn't on the market for at least 10 years.
And I'd ask the prescribing doctors if he has any affiliation whatsoever with the drug's maker.
I'd take none that were approved by the Bush Administration's FDA.
Evelyn Pringle
opinions are like assholes everbody has one THIS IS ONLY FOR RESPONCE. I HOPE YOU DONT LIVE TO REGRET YOUR STUPID COMMENT
My wife is dying because of a diet pill she took ten years ago. Our family will never be the same. Everyday I look at my wife and know my timed is limited with her. She is only 54 years old and we have been married 37 years.Although I have 2 daughters and 7 grandchildren I don't know how to live without her. She has pulmonary hypertension caused by this diet drug.Pre-emption would let the big drug company get by with killing people. Wonderful,loving and caring people like my wife. The drug companies will hide anything they can just to keep the drugs on the market.Even knowing they were killing people. I sure hope Obama is willing to help us.
oh john. i am very sorry for whats happening to your wife. Thats one of the reasons RESPONCE"S comment made me so angry saying we need an escape goat. No we dont need an excape goat we need justice. allowing preemption would be a terrible mistake........... imagine how lapse they would be if they had nothing to worry about as far as law suites. i truly beleive obaba will not let this happen. i hope with all my heart for our kids and grandkids he will not allow preemption
Preemption will be coming up in Congress & the Senate in the next few months. I encourage everyone to write to their respective Congressmen/Women and Senators regarding your feelings about "preemption". It is very wrong and destroys our civil rights as Americans. It is not only for Pharmaceuticals but for Medical Device Manufacturers as well. If Congress & the Senate is bombarded with concerns of ordinary citizens of this country, perhaps they will sit up and take notice. Don't let the big, greedy, corporations take away our day in court....nor the Supreme Justice system. The big corporations are hiding under the "blanket" of the FDA. Why shouldn't they - our Government is allowing it to happen. Please write all and everyone you can think of. As a 42 year RN in the Medical field, I can say that this is outrageous.
I am posting this again, since a number of old Pharmalot friends have joined the discussions on PharmaLittle, and preemption has been a key issue for many of us for a very long time.
FOR FRIENDS WHO STILL STOP BY... In fondest tribute to Ed Silverman and his extraordinary Pharmalot site, and with appreciation to the Newark Star Ledger for sponsoring Pharmalot, a few of us Pharmalot "refugees" have founded the site, "Pharmalittle" - http://pharmalittle.blogspot.com/ This is an all-volunteer, unfunded effort. Needless to say, it ain’t no Pharmalot. But we do our best to keep some of the conversations going and, to our great satisfaction, that is what is happening. Hope to see you there.
my father-in-law was involved in the guidant tabacle. he died from a recalled defibrillator. you know what the courts gave us? $1600 for the entire family! $400 per adult child. what a crock! can guidant be liable if obama does away with preemption as he promised? we rather have our family member back, but more money could help. besides, getting such a low amount on a lawsuit would hardly hurt guidant corporation and are not too pressed to do this again and hurt others. is there a petition to sign to get what we really deserve?